On May 12
th
2017, the China Food and Drug Administration issued an Announcement on Soliciting Opinions on the Relevant Policies on Encouraging Innovation in Drug and Medical Equipment and Protecting the Rights and Interests of Innovators.
According to the new Draft, China intend to establish the drug patent linkage system. The intended new system including below procedures:
1) The drug registration applicants shall submit the statements on relevant rights involved which they have already known and should know when filing an application for drug registration;
2) In the case. the applicant who challenges relevant drug patents, they are required to state that their challenge shall not constitute an infringement on relevant drug patents and notify the relevant drug patent holders of its challenge within 20 days and the relevant drug patent holder may bring a patent infringement suit to the judicial authority within 20 days upon receipt of the applicant’s notice and notify the drug evaluation institution at the same time;
3) Once the drug evaluation institution receive the relevant supporting documents on opening a file on the patent infringement case from the judicial authorities, the institutions may set a pending period lasting for up to 24 month. And during such period the technical appraisal work on accepted drug registration applications shall not be ceased.
4) The drug evaluation institution will decide to approve or reject the drug applied for registration, depending on the compromise conclusion reached between parties concerned or the effective ruling made by the judicial authorities. However, if the judicial authorities fail to make an infringement ruling beyond the pending period, the drug appraisal institutions shall be allowed to approve drug coming on the market.
5) In the case the applicants have not stated that such applications involve relevant patents while the patent holders file an infringement suit, the drug appraisal institutions shall set such a pending period for such applications according to the case handling results of the judicial authorities
By introducing the patent non-infringement declaration, the pending period for approval and other procedures, the new Draft will primarily establish the drug patent linage system in China and will be better protect patent holders against the infringement of their rights and safeguard the patent rights at the time when an application is filed for launching the drug into the market, which will be on a large extent to reduce the disputes over infringement on the drug patent.